Surgical sponge and method of making

ABSTRACT

A surgical sponge comprising, a sheet of absorbent material comprising entangled fibers. The sponge has an elongated radiopaque element in the sheet, with the fibers being entangled about the element to retain it in place in the sheet.

This application is a continuation-in-part of Ser. No. 779,541, filed Sept. 24, 1985 now U.S. Pat. No. 4,645,499, a continuation of Ser. No. 525,528, filed Aug. 22, 1983 now abandoned.

BACKGROUND OF THE INVENTION

The present invention relates to absorbent articles, and more particularly to surgical sponges.

Surgical sponges are commonly used during surgical procedures to absorb body fluids of the patient both inside the incision and around the site of surgery. Sponges of this nature are usually made of an open-meshed absorbent fabric, such as oven cotton.

It is important, of course, that all of such sponges be removed from the patient's body after surgery is complete and before the incision has been closed. Accordingly, it is a standard procedure for the surgical team to carefully count the sponges to reduce the possibility that a sponge may be left in the patient.

In spite of such safety measures, sponges have been occasionally lost, particularly when an unexpected emergency disrupted the normal operative routine such as counting, which is subject to human error. When saturated by body fluids, such as blood, the sponges become significantly reduced in size and assume a color the same as body tissue, thus making visual detection of the sponges extremely difficult. As a result, it has been required to provide the sponges with a flexible insert which is opaque to X-rays. In case of a disputed or non-tallying sponge count in the operating room, or in case of unexpected or unexplainable post-operative discomfort on the part of the patient, a portable X-ray unit is brought to the patient and an X-ray exposure should reveal the presence or absence of a lost sponge. A negative plate should be reassurance to the surgeon that he and his operative team have not left a sponge in the patient. However, the radiopaque elements have normally been loosely placed in the sponge, resulting in the possibility that the elements might fall out of the sponge, and become lost in the patient's body.

The following U.S. patents are incorporated herein by reference: U.S. Pat. Nos. 3,485,706, and 3,494,821. The following U.S. patents relate to non-woven materials: U.S. Pat. Nos. 2,862,251, and 3,068,547.

SUMMARY OF THE INVENTION

A principal feature of the present invention is the provision of a surgical sponge of simplified construction which prevents mishaps in reclaiming sponges from a patient's body.

The sponge of the present invention comprises, a sheet of absorbent material comprising entangled fibers. The sponge has an elongated radiopaque element in the sheet.

A feature of the invention is that the fibers are entangled about the element.

Another feature of the invention is that the entangled fibers retain the element in place in the sheet.

Yet another feature of the invention is that the element is retained in place without the necessity of bonding the element to the sheet thus preventing degradation of the element.

A further feature of the invention is the provision of a method for making the sponge of the present invention.

Further features will become more fully apparent in the following description of the embodiments of this invention and from the appended claims.

DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a perspective view of a surgical sponge of the present invention;

FIG. 2 is a fragmentary plan view of a portion of the sponge of the present invention;

FIG. 3 is a fragmentary sectional view taken substantially as indicated along the line 3--3 of FIG. 2; and

FIG. 4 is a diagrammatic view of a method or apparatus for making the sponge of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIGS. 1 and 2, there is shown a surgical sponge generally designated 10 comprising a sheet 12 of absorbent material comprising entangled fibers, and an elongated radiopaque element 14 embedded in the fibers in order to retain it in place. As shown in FIG. 1, in a preferred form, the sheet 2 is folded into a multi-ply configuration for use in and about &he incision in a patient's body.

The fibers are randomly disposed in the sheet 12, and referably comprise a hydrophilic material, such as rayon or cotton and may be either natural or synthetic. The radiopaque element 14 may comprise a thermoplastic vinyl material impregnated with barium sulfate to make the element 14 opaque to X-rays. The element 14 may be disposed in any suitable pattern or in a straight line in the sheet 12.

With reference to FIG. 3, the fibers 16 of the sheet 12 are entangled with each other in order to provide the sheet 12 with strength and integrity. Also, as shown, the fibers 16 are entangled about both sides of the element 14 in order to hold the element 14 in place in the sheet 12, and prevent loss of the element 14 in a patient's body.

A method of making the sponge 10 will be described in connection with FIG. 4. As shown, the apparatus or method has a first layer or card 18 comprising a mass of randomly disposed fibers which is unwound from a roll 20 and passed in the direction as indicated by the arrow. Also, the apparatus or method has a second layer or card 22 comprising a mass of randomly disposed fibers which is unwound from a roll 24 and passed in the direction as indicated by the arrow slightly above and adjacent to the first layer 18. The method or apparatus has an elongated radiopaque element 26 of the type previously described which is unwound from a roll 28, and which is placed intermediate the first layer 18 and second layer 22 and passed in the direction passed by the first and second layers 18 and 22. The first layer 18, second layer 22, and element 26 are passed through a hydroentangling station 30 where water jets 32 force water against the fibers of the first and second layers 18 and 22, such that the fibers of the first and second layers 18 and 22 are entangled together and are entangled about the element 26 in order to retain it in place between the entangled fibers. The water passing through the layers 18 and 22 then pass through a screen 34 for appropriate disposal. The resulting web 26 from the station 30 containing the locked-in element 26 passes from the station 30, and may be wound into a roll 38. The roll 38 may be subsequently slitted to an appropriate shape, and the slitted fabric may be folded into a multi-ply configuration to form the surgical sponge, as shown in FIG. 1.

Thus, in accordance with the present invention, a sheet 12 of nonwoven material comprising hydroentangled fibers is formed, with the fibers being entangled about a radiopaque element 14 in order to retain the element 14 in place in the sheet 12. In this manner, the element 14 is prevented from falling out of the sponge 10 when used in the patient's body, thus preventing loss of the element 14 in the patient's body.

The foregoing detailed description is given for clearness of understanding only, and no unnecessary limitations should be understood therefrom, as modifications will be obvious to those skilled in the art. 

I claim:
 1. A method of making a surgical sponge, comprising the steps of:passing a first layer of a mass of fibers; passing a second layer of a mass of fibers adjacent the first layer; placing an elongated radiopaque element intermediate the first and second layers; and entangling the fibers of the first and second layers together and about said element to form a sheet of entangled fibers with the element embedded inside the sheet.
 2. A surgical sponge including an integral X-ray detectable element, said sponge comprising a fibrous, nonwoven fabric consisting essentially of entangled fibers arranged in an interconnecting relationship, in the fabric, and at least one X-ray detectable element positioned interiorly of said fibrous nonwoven fabric, the fibers of said nonwoven fabric being intertwined about said X-ray detectable element. 